Device Classification Name |
humidifier, non-direct patient interface (home-use)
|
510(k) Number |
K842275 |
Device Name |
ULTRASONIC COOL SPRAY HUMIDIFIER |
Applicant |
SUNBEAM CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SUNBEAM CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.5460
|
Classification Product Code |
|
Date Received | 06/08/1984 |
Decision Date | 08/14/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|